Human Chorionic Gonadotrophin

• Infertility in women
• Induction of ovulation in women with anovulatory infertility (including polycystic ovary syndrome) who have undergone follicle-stimulating hormone (FSH) or human menopausal gonadotrophin (hMG) stimulation.
• Final maturation of oocytes prior to intrauterine insemination (IUI) or in vitro fertilization (IVF) cycles.
• Infertility in men
• Treatment of hypogonadotropic hypogonadism in adult males to stimulate endogenous testosterone production and spermatogenesis, often in combination with FSH.
• Prepubertal cryptorchidism
• Induction of testicular descent in selected pediatric cases when surgical intervention is delayed or as adjunct therapy.
• Off-label/adjunct uses
• Support of luteal phase in assisted reproductive technology (ART) cycles.
• Treatment of delayed puberty in males with hypogonadotropic hypogonadism.
• Occasionally used in weight management protocols or bodybuilding under strict medical supervision (not recommended without clinical indication).

Dosing varies by indication, patient age, sex, and treatment protocol. Administered intramuscular (IM) or subcutaneous (SC).

• Women (ovulation induction)
• Typical adult dose: 5,000–10,000 IU IM or SC as a single injection to trigger ovulation following gonadotrophin therapy.
• Timing: 34–36 hours prior to planned insemination or oocyte retrieval.
• Dose adjustments may depend on follicle number, estradiol levels, and risk of ovarian hyperstimulation syndrome (OHSS).
• Women (ART cycles – oocyte maturation)
• Recombinant hCG: 250 µg SC as single dose; alternative: 10,000 IU urinary-derived hCG IM.
• Dose may be adjusted based on ovarian response and protocol specifics.
• Men (hypogonadotropic hypogonadism)
• Initial: 1,000–2,000 IU SC or IM 2–3 times weekly.
• Duration: 3–6 months or longer, often in combination with FSH, until adequate spermatogenesis and testosterone levels are achieved.
• Pediatric use (cryptorchidism)
• 500–1,000 IU IM twice weekly for 5 weeks, or as per specialized pediatric endocrinology protocols.
• Special populations
• No routine renal or hepatic dose adjustments; individualize for severe comorbidities or concomitant hormone therapy.
• Monitor for hypersensitivity or allergic reactions, especially in pediatric populations.

hCG is a glycoprotein hormone structurally similar to luteinizing hormone (LH). It binds to LH receptors in the ovary and testis. In women, hCG stimulates the final maturation of ovarian follicles, triggers ovulation, and supports corpus luteum function, enhancing progesterone production. In men, hCG stimulates Leydig cells in the testes to produce testosterone, which is essential for spermatogenesis and secondary sexual characteristics. The pharmacological effect mimics natural LH surge, enabling precise control of reproductive physiology.

• Absorption: Rapidly absorbed after IM or SC injection; peak plasma levels typically achieved within 6–12 hours.
• Distribution: Widely distributed in extracellular fluid; binds minimally to plasma proteins.
• Metabolism: Cleaved primarily in the liver and kidneys into inactive fragments.
• Excretion: Fragments excreted renally; intact hCG has a half-life of approximately 24–36 hours after single dose.
• Onset & duration: Clinical effects on ovulation or testosterone production occur within hours to days depending on indication and co-administered therapies.

• Pregnancy: Category X for direct administration in pregnant women (contraindicated). Use in ovulation induction is prior to conception.
• Lactation: Data are limited. Caution is advised; excretion into breast milk is minimal. Therapy is generally discontinued once pregnancy is achieved, so lactation exposure is rare.

• Primary therapeutic class: Reproductive hormone / gonadotrophin.
• Subclass: Glycoprotein hormone, luteinizing hormone analogue.

• Known hypersensitivity to hCG or any formulation components.
• Pregnancy (should not be administered once pregnancy is confirmed).
• Hormone-sensitive malignancies (ovarian, breast, testicular, or prostate cancer) unless under strict specialist supervision.
• Active undetected abnormal uterine bleeding.
• Severe ovarian cysts unrelated to infertility treatment.

• Ovarian hyperstimulation syndrome (OHSS): Risk increases with high gonadotrophin exposure; monitor for abdominal pain, bloating, or sudden weight gain.
• Multiple pregnancies: Ovulation induction may increase risk of twins or higher-order gestation; counsel patients accordingly.
• Thromboembolic events: Rare but possible; observe for signs of thrombosis during treatment, especially in high-risk patients.
• Hypersensitivity/anaphylaxis: Rare but serious; monitor during and after injection.
• Pediatric patients: Only for cryptorchidism under endocrinologist supervision.
• Men with testicular disease: Monitor testosterone levels and spermatogenesis; adjust dose as required.

• Common
• Injection site pain, redness, or swelling.
• Headache, fatigue, irritability.
• Mild abdominal discomfort or bloating in women.
• Less common / serious
• OHSS (abdominal distension, rapid weight gain, ascites).
• Mood swings, depression, or breast tenderness in men.
• Rare allergic reactions: rash, urticaria, or anaphylaxis.
• Rare thromboembolic events (deep vein thrombosis, pulmonary embolism).
• Timing & dose-dependence
• Side effects may occur within hours to days of administration; OHSS risk is dose-dependent and related to ovarian response.

• Other gonadotrophins: Co-administration is standard for ovulation induction; dose timing critical to avoid overstimulation.
• Clomiphene citrate: May be used sequentially or in combination; monitor for additive ovarian stimulation.
• Testosterone therapy: Men on concurrent testosterone require monitoring of endogenous and exogenous hormone effects.
• No known CYP450 interactions: hCG is a protein hormone, metabolized proteolytically, with minimal risk for hepatic enzyme-mediated drug interactions.

• ART protocols: Recombinant hCG now often preferred over urinary-derived hCG for precision and reduced risk of viral contamination.
• Low-dose hCG protocols: Emerging evidence supports using low-dose hCG alongside FSH to reduce OHSS while maintaining ovulation efficacy.
• Extended use in men: Optimized combination protocols with FSH improve spermatogenesis in hypogonadotropic hypogonadism.
• Monitoring trends: Increased use of individualized dosing and hormone-level monitoring to reduce adverse effects and improve ART outcomes.

• Temperature: Store 2°C–8°C (refrigerate); do not freeze unless product labeling permits.
• Light & humidity: Protect from direct light; keep in original packaging until use.
• Reconstitution & handling: Reconstitute lyophilized products with provided sterile diluent; use immediately after reconstitution unless otherwise specified. Inspect solution for particulate matter before injection.
• Shelf life: Follow manufacturer expiration dates; discard unused reconstituted solution as recommended.